| | | | | | | | | | |
|
|
|
|
| Dockets Entered
On September 11, 2007
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1978N-0038
|
| Sunscreen Drug Products
|
|
|
|
|
| 1996N-0144
|
| OTC-Colloidal Silver Ingredients or Silver Salts
|
|
|
|
|
| 1998N-0359
|
| Program priorities/Center for Food Safety & Applied Nutrition
|
|
|
|
|
| 2006N-0454
|
| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
|
|
|
|
|
| 2006P-0158
|
| Revoke regulations that provided for the inclusion and addition of sucralose as a non-nutritive sweetener in food
|
|
|
|
|
| 2006P-0405
|
| Require full prescribing information of all antiepileptic drugs contain specific language under Warnings or Warnings and Precautions
|
|
|
|
|
| 2007D-0234
|
| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin
|
|
|
|
|
| 2007P-0093
|
| Refuse to approve CIP-TRAMADOL ER until Cipher complies with the investigations Reports to show the safety and effectiveness of the drug
|
|
|
|
|
| 2007P-0094
|
| Switch Allegra (Fexofendaine Hydrochloride), and Zyrtec (Cetirzine Hydrochloride) and Zyrtec D (Cetirizine Hydrochloride; Pseudophedrine Hydrochloride) from prescription drugs to over-the- counter
|
|
|
|
|
|
| 2007P-0297
|
| Request to reconsider the failure to approve Provenge
|
|
|
|
|
| 2007V-0338
|
| Variance for an Alternate Beam Attenuator
|
|
| |
|
| 1978N-0038
|
| Sunscreen Drug Products
|
|
|
|
|
| EC 2376
|
| Miss. Jenn Epstein
|
| Vol #:
|
| 161
|
|
|
|
|
| EC 2377
|
| Mrs. Marty Searle
|
| Vol #:
|
| 161
|
|
|
|
|
| EC 2378
|
| Miss. Myra Delzeit
|
| Vol #:
|
| 161
|
|
|
|
|
| EC 2379
|
| Ms. jennifer wong
|
| Vol #:
|
| 161
|
|
|
|
|
| 1996N-0144
|
| OTC-Colloidal Silver Ingredients or Silver Salts
|
|
|
|
|
| ANS 4
|
| HFW-1 to Congress of the United States
|
| Vol #:
|
| 7
|
|
|
|
|
| 1998N-0359
|
| Program priorities/Center for Food Safety & Applied Nutrition
|
|
|
|
|
| C 128
|
| Anthony L. Young
|
| Vol #:
|
| 10
|
|
|
|
|
| C 129
|
| Juice Products Association
|
| Vol #:
|
| 10
|
|
|
|
|
| C 130
|
| Cosmetics, Toiletry, and Fragrance Association (CTFA)
|
| Vol #:
|
| 10
|
|
|
|
|
| EC 411
|
| Winston-Salem State University
|
| Vol #:
|
| 12
|
|
|
|
|
| EC 412
|
| American Association for Justice
|
| Vol #:
|
| 12
|
|
|
|
|
| EC 413
|
| National Milk Producers Federation
|
| Vol #:
|
| 12
|
|
|
|
|
| EC 414
|
| GMA/FPA
|
| Vol #:
|
| 12
|
|
|
|
|
| EC 415
|
| FAAN
|
| Vol #:
|
| 12
|
|
|
|
|
| EC 416
|
| International Formula Council
|
| Vol #:
|
| 12
|
|
|
|
|
| EC 417
|
| Natural Products Association
|
| Vol #:
|
| 12
|
|
|
|
|
| 2006N-0454
|
| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
|
|
|
|
|
| EC 42
|
| Mr. Daniel Waite
|
| Vol #:
|
| 16
|
|
|
|
|
| EC 43
|
| COPD Foundation
|
| Vol #:
|
| 16
|
|
|
|
|
| EC 44
|
| Alpha-1 Advocacy Alliance
|
| Vol #:
|
| 16
|
|
| | | | | | | | |
|
| |
|
| EC 45
|
| Individual User of Maxair Autohaler
|
| Vol #:
|
| 16
|
|
|
|
|
| EC 46
|
| Ms. Bridget Lowery
|
| Vol #:
|
| 16
|
|
|
|
|
| EC 47
|
| Ms. Joanne Grace
|
| Vol #:
|
| 16
|
|
|
|
|
| EC 48
|
| Boehringer Inghelheim Pharmaceuticals, Inc.
|
| Vol #:
|
| 16
|
|
|
|
|
| EC 49
|
| Abbott
|
| Vol #:
|
| 16
|
|
|
|
|
| EC 50
|
| American Pharmacists Association (APhA)
|
| Vol #:
|
| 16
|
|
|
|
|
| EC 51
|
| International Pharmaceutical Aerosol Consortium
|
| Vol #:
|
| 16
|
|
|
|
|
| 2006P-0158
|
| Revoke regulations that provided for the inclusion and addition of sucralose as a non-nutritive sweetener in food
|
|
|
|
|
| EMC 211
|
| Greg Baker
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC 212
|
| Kamie Stoner
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC 213
|
| Mary L. Stephens
|
| Vol #:
|
| 1
|
|
| |
|
| 2006P-0405
|
| Require full prescribing information of all antiepileptic drugs contain specific language under Warnings or Warnings and Precautions
|
|
|
|
|
| C 8
|
| University of Pennylvania Medical Center
|
| Vol #:
|
| 2
|
|
|
|
|
| 2007D-0234
|
| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin
|
|
|
|
|
| C 3
|
| Henkel Corporation R&D
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007P-0093
|
| Refuse to approve CIP-TRAMADOL ER until Cipher complies with the investigations Reports to show the safety and effectiveness of the drug
|
|
|
|
|
| LET 1
|
| Jane A. Axelrad
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007P-0094
|
| Switch Allegra (Fexofendaine Hydrochloride), and Zyrtec (Cetirzine Hydrochloride) and Zyrtec D (Cetirizine Hydrochloride; Pseudophedrine Hydrochloride) from prescription drugs to over-the-counter
|
|
|
|
|
|
|
|
|
| LET 1
|
| Jane A. Axelrad
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007P-0297
|
| Request to reconsider the failure to approve Provenge
|
|
|
|
|
| C 6
|
| Robert L. Range
|
| Vol #:
|
| 1
|
|
|
|
|
| C 7
|
| Joe Nadolny
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007V-0338
|
| Variance for an Alternate Beam Attenuator
|
|
|
|
|
| ACK 1
|
| FDA/ DDM/ to Palomar Medical Technologies, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| VAR 1
|
| Palomar Medical Technologies, Inc.
|
| Vol #:
|
| 1
|
|
